Pfizer teams with Clear Creek Bio on new COVID-19 treatment

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Pfizer and Clear Creek Bio, a biotech startup based in Cambridge, Massachusetts, have partnered to develop a new COVID-19 treatment they hope will provide greater efficacy as the virus evolves and proves increasingly resistant to current treatments.

The agreement is to advance the discovery and development of potential inhibitors of the SARS-CoV-2 papain-like protease (PLpro) for the oral treatment of COVID-19. PLpro is an essential enzyme, which, along with the main protease (Mpro), plays an important role in viral replication.

The program is expected to complement Pfizer's existing portfolio of coronavirus treatments with direct-acting antiviral agents, according to the companies.

WHAT'S THE IMPACT?

Under the terms of the agreement, the two companies will work together to identify a PLpro candidate to progress into the clinic, at which time Pfizer will be solely responsible for further development and commercialization activities. 

Clear Creek Bio will receive an undisclosed upfront payment and will be eligible to receive additional potential milestone payments, plus royalties on future product sales.

SARS-CoV-2, the virus that causes COVID-19, has two essential proteases, the main protease (Mpro) and the papain-like protease (PLpro), both required to fully process the viral polyprotein and assemble a functional replicase complex. In addition to its critical role in viral replication, the PLpro also contributes to dysregulation of host innate immunity and immune evasion.

Charlotte Allerton, chief scientific officer for anti-infectives and head of medicine design at Pfizer, said it's critical to stay ahead of the virus and all of its adaptations and mutations.

"COVID-19 has proven to be a devastating and highly unpredictable disease, one with the potential to remain a global health concern for years to come," she said.

"As COVID-19 continues to evolve, there is a significant need for oral antivirals with novel mechanisms of action," said Dr. Vikram Sheel Kumar, CEO of Clear Creek Bio. "We explored the druggable SARS-CoV-2 genome and identified PLpro as a promising and untapped target."

THE LARGER TREND

The announcement comes as Pfizer is seeking FDA approval for its bivalent respiratory syncytial virus (RSV) vaccine candidate. The company will seek approval before the end of the calendar year.

RSV is a respiratory virus, and while its cold-like symptoms are typically mild, it can in some instances cause a deeper illness in children and older adults specifically. The vaccine, which is intended for pregnant women, is designed to pass immunity onto the child, who retains it after the child's birth.

In the clinical trial, the vaccine demonstrated efficacy of almost 82% against severe RSV in infants from birth through the first 90 days of life. After that, the vaccine showed a still-high efficacy of 69.4% through the first six months of life.

If approved, Pfizer's RSV vaccine candidate could be the first maternal vaccine available to help prevent RSV in young infants. Pfizer is currently the only company with an investigational vaccine for RSV in both infants and older adults.
 

Twitter: @JELagasse
Email the writer: Jeff.Lagasse@himssmedia.com